Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT03483792
Eligibility Criteria:
Inclusion Criteria:
* Having a pre-conceptional infertility assessment in the gynecology-Endocrinology department of University Hospital of Lille
* in the first trimester of mono fetal pregnancy (between 5 and 10 weeks of gestation), obtained spontaneously, after induction of ovulation or Assisted Reproductive Techniques (ART)
* Pregnancy followed at University Hospital of Lille
* PCOS group: defined according to modified Rotterdam criteria (2003 and 2011)
* At least 2 of the following 3 criterion:
* Cycle disorder
* Clinical and / or biological hyperandrogenism
* Ovarian volume \> 10cm³ and/or more than 19 follicles from 2 to 9 mm per ovary
* After exclusion of other causes of cycle disorder or hyperandrogenism
* Control group: patient with severe male and / or tubal infertility, no cycling disorder, normal ovarian reserve (FSH\<10 IU / L, E2\<50 pg / ml, AMH\>7 and \<35 pmol / L and Follicles count between \>5 and \<20 per ovary at day 3 of the cycle).
In the group of female controls, the fertility problem is not related to a female pathology of the hypothalamic-pituitary-ovarian axis (tubal or male infertility). They are women without ovarian personal pathology. The problem of fertility being of other origin.
Exclusion Criteria:
* Multiple pregnancy
* Pregnancy after egg donation
* Long-term drug therapy (excluding routine pregnancy supplementation)
* Previous Diabetes
* Bariatric surgery
* Patients with ovulatory infertility of central or idiopathic origin
* Patients already included in another protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
43 Years
Study:
NCT03483792
Study Brief:
Protocol Section:
NCT03483792